A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

Completed · Phase 2 · Has a placebo group

Conditions studied: Solid Tumor

In brief

The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.

Key facts

Study ID

NCT00786838

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

76

Starts

2008-10-01

Expected to finish

2009-12-01

Last updated by the study team

2014-04-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with locally advanced or metastatic solid tumors who have received three or less prior lines of systemic chemotherapy
• Participants must have relapsed or had progressive disease following standard of care treatment with chemotherapy prior to enrollment, or intolerant to prior standard of care treatment with chemotherapy
• Normal cardiac conduction and function as documented on a 12-lead electrocardiogram
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
• Adequate organ function as evidenced by laboratory tests
• Able to receive dexamethasone or its equivalent
• Agrees to protocol-defined use of effective contraception

You may not qualify if…

• Participants treated with more than three prior chemotherapy regimens (including adjuvant therapy)
• Previous exposure to trabectedin
• Central nervous system (CNS) metastasis
• Known hypersensitivity to any of the components of the trabectedin intravenous formulation or dexamethasone
• Heart rhythm disturbances, unusual T wave and U wave (if present) morphology, blood pressure outside of normal range, a history of cardiac failure, myocardial infarction, or cardiomyopathy, or a history of additional risk factors for torsade de pointes (eg, heart failure, electrolyte abnormalities, family history of Long QT Syndrome)
• Participants who at screening are on medication that is known to prolong the QT interval or who is on CYP3A4 inhibitors or inducers

Where it is running

• Study site — Miami, Florida, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Tacoma, Washington, United States
• Study site — Brussels, Belgium
• Study site — Edegem, Belgium
• Study site — Wilrijk, Belgium
• Study site — Lyon, France
• Study site — Marseille, France
• Study site — Montpellier, France
• Study site — Villejuif, France
• Study site — Bengaluru, India
• Study site — Pune, India
• Study site — Moscow, Russia
• Study site — Saint Petersburg, Russia
• Study site — Seoul, South Korea
• Study site — PAU de Sanchinarro, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.